Eosinophilic FasciitisNCT05915585
High-Intensity Laser Therapy for Eosinophilic Fasciitis
A study testing High-Intensity Laser Therapy in people with Eosinophilic Fasciitis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Eosinophilic Fasciitis
- What is being tested?
- High-Intensity Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jun 2023to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with Eosinophilic fasciitis.
Who cannot join
- a diagnosis unrelated to Eosinophilic fasciitis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Efficacy of High-Intensity Laser Therapy for the Management of Eosinophilic Fasciitis: A Case Report
Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. This case report will describe use of high-intensity laser therapy (HILT) using the Mectronic Exand MY high-intensity laser system in a patient with EF, highlighting its potential as an alternative or adjunct treatment option.
- Conditions
- Eosinophilic Fasciitis
- Being tested
- High-Intensity Laser Therapy
- Medical subject headings
- Eosinophilic Fasciitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser TherapyDevice
The patient will receive HILT using the Mectronic Exand MY high-intensity laser system with the following parameters:
Wavelength: 1064 nm (near-infrared) Power: 12 W Energy density: 8 J/cm² Pulse duration: 200 µs Treatment duration: 10 minutes Frequency: 3 sessions per week for 4 weeks Total energy delivered: 96 J per treatment session
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Not described Receives: Device: High-Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity via Numeric pain rating scale
Measured: Changes in pain intensity at baseline and 4 weeks
Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Measured: Changes in DASH at baseline and 4 weeks
Quality of life via Short Form-36 Health Survey
Measured: Changes in Short Form-36 Health Survey at baseline and 4 weeks
Adverse event
adverse events are recorded by the patient and therapist
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start18 Jun 2023 (estimated)
- Primary completion19 Jul 2023 (estimated)
- Study completion20 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single participant case study
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915585
- Sponsor's protocol ID
- 010/012023
- Status last verified
- Jun 2023
- First submitted
- 14 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Intensity Laser Therapy for the Management of Eosinophilic Fasciitis: A Case Report
- ClinicalTrials.gov ID
- NCT05915585
- Acronym / sponsor ID
- 010/012023
- Conditions
- Eosinophilic Fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 18 Jun 2023 (estimated)
- Primary completion
- 19 Jul 2023 (estimated)
- Study completion
- 20 Jul 2023 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Eosinophilic fasciitis (EF) is a rare musculoskeletal disorder characterized by inflammation and thickening of the fascia, leading to pain, stiffness, and functional impairment. Conventional treatment options include immunosuppressive medications, corticosteroids, and physical therapy. This case report will describe use of high-intensity laser therapy (HILT) using the Mectronic Exand MY high-intensity laser system in a patient with EF, highlighting its potential as an alternative or adjunct treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single participant case study
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) | Experimental | Device: High-Intensity Laser Therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with Eosinophilic fasciitis.
Key exclusion criteria (1 listed)
- a diagnosis unrelated to Eosinophilic fasciitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Laser TherapyThe patient will receive HILT using the Mectronic Exand MY high-intensity laser system with the following parameters: Wavelength: 1064 nm (near-infrared) Power: 12 W Energy density: 8 J/cm² Pulse duration: 200 µs Treatment duration: 10 minutes Frequency: 3 sessions per week for 4 weeks Total energy delivered: 96 J per treatment session | Device | High-Intensity Laser Therapy (HILT) |
Primary outcome
Pain intensity via Numeric pain rating scale
Time frame: Changes in pain intensity at baseline and 4 weeks
Functional outcomes via Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Time frame: Changes in DASH at baseline and 4 weeks
Quality of life via Short Form-36 Health Survey
Time frame: Changes in Short Form-36 Health Survey at baseline and 4 weeks
Adverse event
Time frame: 4 Weeks
adverse events are recorded by the patient and therapist
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Eosinophilic Fasciitis
RecruitingObservational study
EFESO: Study on Juvenile Onset Eosinophilic Fasciitis
Eosinophilic Fasciitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy in people with Eosinophilic Fasciitis, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity via Numeric pain rating scale (time frame: Changes in pain intensity at baseline and 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.